GV20 Therapeutics (GV20), a clinical-stage AI-powered biotherapeutics company, today announced that Dr. Kristopher Wentzel from the Angeles Clinic and Research Institute presented updated clinical and translational data of GV20-0251 monotherapy from the ongoing Phase 1/2 clinical trial evaluating GV20-0251 in patients with advanced solid tumors resistant to anti-PD(L)1 and other standard therapies (NCT05669430) at the American Society of Clinical Oncology 2025 Annual Meeting. GV20-251 is the first clinical stage, AI-designed antibody therapeutic against an AI-predicted target in the clinic.
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The presentation highlights favorable safety profile, promising monotherapy efficacy, substantial immune activation, and desirable pharmacokinetic properties in patients with advanced solid tumors.
Key highlights from the presentation:
— Favorable safety profile
— No dose-limiting toxicity up to 20mg/kg, highest dose tested
— All treatment-related adverse events (TRAEs) are grade 1 or 2, except 1 grade 3 TRAE
— Monotherapy efficacy
— 3 confirmed partial responses and 3 more with tumor shrinkage (ORR 33.3%, DCR 66.7%) observed in 9 patients with cutaneous melanoma with primary resistance to anti-PD1
— 2 of the 3 partial responders have liver metastasis with 1 on treatment > 14 months
— Additional tumor shrinkage in non-small cell lung cancer and cervical cancer
— Translational insights
— LinearPK with T1/2 of 26 days and full target occupancy observed with top two dose levels
— Substantial immune activation with increased T andNK cell infiltration observed with treatment, consistent with the mechanism of action and preclinical findings
Detail of the presentation can be found on gv20tx.com.
ABOUT GV20 THERAPEUTICS
GV20 Therapeutics is a clinical-stage biotech company dedicated to developing next-generation cancer biotherapeutics. GV20's AI-driven STEAD platform integrates massive B cell repertoire data, -omics data, and advanced AI models to provide deep insights into the tumor microenvironment and uncover targets and therapeutic antibodies that elude other approaches. GV20's pipeline includes best-in-class and first-in-class monoclonal and bispecific antibodies, as well as antibody-drug conjugates (ADCs). The lead program, GV20-0251, is an AI-designed, first-in-class, fully human monoclonal antibody targeting the novel immune checkpoint IGSF8 (Li et al, Cell 2024). GV20-0251 advanced from target discovery to IND in three years, marking a paradigm shift in AI-driven antibody drug discovery. Preclinical studies show that anti-IGSF8 antibodies enhance NK cell cytotoxicity, dendritic cell antigen presentation, and T cell activation, both alone and with anti-PD1. In an ongoing Phase 1/2a trial (NCT05669430) for advanced solid tumors, GV20-0251 demonstrated favorable safety and promising monotherapy efficacy (Wentzel et al, ASCO 2025).
To learn more about GV20, please visithttps://gv20tx.com/and follow the company on LinkedIn.
Business ContactYing Gong, Ph.D., CBOBD@gv20tx.com
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SOURCE GV20 Therapeutics
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